Ceramic bone graft substitute vs autograft in XLIF: a prospective randomized single-center evaluation of radiographic and clinical outcomes

Abstract

Purpose of the Study The objective of this prospective, parallel, randomized, single-center study is to evaluate the clinical success of a commercial ceramic bone graft substitute (CBGS) for autograft in eXtreme Lateral Interbody Fusion (XLIF) procedures. Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Author 1 Given name: [Cristiano Magalhães], Last name [Menezes]. Author 2 Given name: [Gabriel Carvalho], Last name [Lacerda]. Author 5 Given name: [Erica Godinho], Last name [Menezes]. Also, kindly confirm the details in the metadata are correct.yes Methods Forty-five adult subjects were consecutively enrolled and randomized into a single-level XLIF procedure using either CBGS or iliac crest bone graft autograft (30 and 15 subjects, respectively). The primary outcome was fusion rate at 12, 18, and 24 months. Secondary outcomes were pain and disability measured by HRQOL questionnaires. Kindly check and confirm whether the corresponding author and his corresponding affiliations is correctly identified.yes Results The fusion rates for both CBGS and autograft groups at the 24-month follow-up were 96.4% and 100%, respectively. For the CBGS group, mean ODI, mean back pain, and mean worst leg pain significantly improved at the 24-month follow-up by 76.7% (39.9–9.3), 77.6% (7.3–1.6), and 81.3% (5.1–1.0), respectively. For the autograft group, mean ODI, mean back pain, and mean worst leg pain significantly improved during the same time period by 77.1% (35.9–8.2), 75.6% (6.1–1.5), and 86.0% (6.6–0.9), respectively (all time points between groups, p < 0.05). Conclusion The results of this prospective, randomized study support the use of CBGS as a standalone bone graft substitute for autograft in single-level XLIF surgery. The clinical performance and safety outcomes reported here are consistent with published evidence on CBGS. Improvements in patient-reported back pain, leg pain, and disability outcomes were comparable between the CBGS and autograft groups.

Emerging Technologies within Spine Surgery

“…Tricalcium phosphate (TCP) is another osteoinductive ceramic bone graft substitute. A randomized, controlled trial investigating ICBG versus TCP in lumbar interbody fusion showed no difference in complications or clinical outcomes, with excellent fusion rates in both treatment groups [82]. Silicon-substituted calcium phosphate is a modified form of TCP with a 93% reported radiographic fusion rate similar to that seen in rhBMP2-impregnated grafts.…”

A Retrospective Review of MagnetOs Easypack PuttyTM Bone Graft Used Standalone in Transforaminal Lumbar Interbody Fusion

“…The 8 subjects had 11 total levels fused and 87.4% were deemed fused at 1 year post-operative [8]. Clinical data also supports the use of AttraX Putty™ and Fibergraft™ in the intervertebral disc space [9,10]. Thirteen subjects (18 levels) were treated with AttraX Putty, which led to an 83% interbody fusion rate at a mean follow-up time of 34.5 months post-operative (12-62 months).…”

“…Thirteen subjects (18 levels) were treated with AttraX Putty, which led to an 83% interbody fusion rate at a mean follow-up time of 34.5 months post-operative (12-62 months). Fibergraft led to a 96.4% fusion rate in eXtreme Lateral Interbody Fusion (XLIF) procedures at 24 months post-operative in a cohort of 30 patients [10]. A range of interbody fusion rates are documented with autograft as low as 77.8% and extending to 100% at 12 months post-operative [11][12][13].…”

An effectiveness and economic analyses of tricalcium phosphate combined with iliac bone graft versus RhBMP-2 in single-level XLIF surgery in Thailand

“…Many studies demonstrated a significant improvement in clinical and radiographic outcomes following XLIF surgery [ 22 ]. Most studies on XLIF use rhBMP-2 as a bone graft replacement; only a few studies have used other bone graft materials such as calcium phosphate [ 12 , 23 , 24 ]. In addition, none of the previous studies used calcium phosphate combined with iliac bone graft in XLIF surgery.…”